Trial · NCT01041781
Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
NCT01041781, Phase 3, Terminated, Alliance for Clinical Trials in Oncology; results first posted 2018-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer. Trials, record NCT01041781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01041781
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
- NCT number
- NCT01041781
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 313 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Lung Cancer
- Interventions
- carboplatin, celecoxib, gemcitabine hydrochloride, pemetrexed disodium, placebo
- First posted
- 2010-01-01
- Last updated
- 2018-07-23
- Results first posted
- 2018-07-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | Time between randomization and disease relapse or death from any cause, assessed up to 5 years | Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. |
| Secondary | Overall Survival | Time between randomization and death from any cause, assessed up to 5 years | Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. |
| Secondary | Response Rate | Up to 5 years | The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test |
| Secondary | Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0 | Up to 5 years | The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment |
| Secondary | Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1) | Up to 5 years | Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the first quartile (Q1, 10.09). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. |
| Secondary | Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Median Quartile (Q2) | Up to 5 years | prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q2, 15.38). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. |
| Secondary | Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Third Quartile (Q3) | Up to 5 years | Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q3, 27.86). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | Time between randomization and disease relapse or death from any cause, assessed up to 5 years | months | MEDIAN | |
| SECONDARY | Overall Survival | Time between randomization and death from any cause, assessed up to 5 years | months | MEDIAN | |
| SECONDARY | Response Rate | Up to 5 years | percentage of patients | NUMBER | |
| SECONDARY | Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0 | Up to 5 years | percentage of patients | NUMBER | |
| SECONDARY | Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1) | Up to 5 years | Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis. | months | MEDIAN |
| SECONDARY | Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Median Quartile (Q2) | Up to 5 years | Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis. | months | MEDIAN |
| SECONDARY | Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Third Quartile (Q3) | Up to 5 years | Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 5.16 | 95% Confidence Interval 4.40 to 5.78 | months | |
| Progression-free Survival | Arm II (Arm B: Placebo + Standard Chemotherapy) | 5.26 | 95% Confidence Interval 4.40 to 6.08 | months | |
| Overall Survival | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 11.4 | 95% Confidence Interval 9.46 to 14.06 | months | |
| Overall Survival | Arm II (Arm B: Placebo + Standard Chemotherapy) | 12.5 | 95% Confidence Interval 9.36 to 13.83 | months | |
| Response Rate | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 40 | 95% Confidence Interval 32 to 48 | percentage of patients | |
| Response Rate | Arm II (Arm B: Placebo + Standard Chemotherapy) | 35 | 95% Confidence Interval 27 to 43 | percentage of patients | |
| Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0 | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 61.04 | percentage of patients | ||
| Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0 | Arm II (Arm B: Placebo + Standard Chemotherapy) | 55.06 | percentage of patients | ||
| Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1) | PGE-M < Q1 | 7.7 | 95% Confidence Interval 4.40 to 13.14 | months | |
| Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1) | PGE-M >= Q1 | 4.9 | 95% Confidence Interval 3.81 to 6.14 | months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 154 | |
| Overall Study | STARTED | Arm II (Arm B: Placebo + Standard Chemotherapy) | 158 | |
| Overall Study | COMPLETED | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 154 | |
| Overall Study | COMPLETED | Arm II (Arm B: Placebo + Standard Chemotherapy) | 158 | |
| Overall Study | NOT COMPLETED | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Arm B: Placebo + Standard Chemotherapy) | 0 |
Source ClinicalTrials.gov
Adverse events448
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 120 | 146 | 566 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Arm B: Placebo + Standard Chemotherapy) | 123 | 148 | 490 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 1 | 146 | 1 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm II (Arm B: Placebo + Standard Chemotherapy) | 1 | 148 | 3 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 3 | 146 | 3 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (Arm B: Placebo + Standard Chemotherapy) | 2 | 148 | 2 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 0 | 146 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm II (Arm B: Placebo + Standard Chemotherapy) | 1 | 148 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 0 | 146 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Arm II (Arm B: Placebo + Standard Chemotherapy) | 1 | 148 | 1 |
1 to 10 of 448Source ClinicalTrials.gov
See all 448 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 15 | 146 |
| Total, all-cause mortality | Arm II (Arm B: Placebo + Standard Chemotherapy) | 9 | 148 |
| Total, other adverse events | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 135 | 146 |
| Total, other adverse events | Arm II (Arm B: Placebo + Standard Chemotherapy) | 140 | 148 |
| Total, serious adverse events | Arm I (Arm A: Celecoxib + Standard Chemotherapy) | 31 | 146 |
| Total, serious adverse events | Arm II (Arm B: Placebo + Standard Chemotherapy) | 21 | 148 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Arm A: Celecoxib + Standard Chemotherapy) vs Arm II (Arm B: Placebo + Standard Chemotherapy): deaths from any cause | Trial comparisons |
| Arm I (Arm A: Celecoxib + Standard Chemotherapy) vs Arm II (Arm B: Placebo + Standard Chemotherapy): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01041781
GET https://conductscience.org/api/trials/v1/NCT01041781/events?page=2